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Director, CMC-QC Biologics & Oligonucleotides
Location:
Novato, CA
Description:
Why Join Us? Be a hero for our rare disease patients At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won't go - challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them.Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth - so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work.If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team . Position Summary: ultra impact - Make a difference for those who need it mostUltragenyx is looking for an experienced professional as Director of CMC Quality Control (CMC QC) with a passion and creativity to manage the quality control aspects of product life cycles for rare and ultra-rare diseases. This role will report the head of Biologics CMC-QC. The key responsibilities will include: Leading all the analytical and CMC control testing activities for the production of Ultragenyx toxicology, clinical trial and commercial products Managing contract organizations including CMOs and Contract Laboratories (CLs) to ensure appropriate compliance with ICH and regulatory quality standards Working with cross-functional teams, including Technical Operations, Technical QA, Project Management, Supply Chain and Regulatory to achieve corporate goals and objectives Develop internal system to manage QC technical knowledge base for all Biologics & Oligonucleotides assets The successful candidate must be proficient in QC and Analytical platforms for Biologics & Oligonucleotides. Th ideal candidate have a track record of cGMP and CMC-QC experience. The candidate has an end-to-end CMC regulatory drug approval process knowledge for Biologics & Oligonucleotides, be a self-starter with the ability to work independently under minimal supervision, and who is seeking to be part of an innovative and fast-paced team. This is a rewarding opportunity to join a commercial Company working on fascinating clinical molecules focused on developing life-transforming therapeutics for patients with rare and ultra-rare diseases. The individual will be instrumental in bringing the company's therapeutic products from early-discovery development stage to commercial launch and be a critical part of creating an innovative team for the development of the company's next generation products. Work Model: Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite. Responsibilities: Provide strategic guidance on all QC related agenda for Biologics & Oligonucleotides assets. Collaborate with analytical development or CRO on method selection, development, qualification/validation, technical transfer and troubleshooting. Execute technical review of analytical data, data integrity and laboratory documentation, method validation protocols, method validation summary reports, and method development reports Participate in the selection of CMOs and CLs (contract laboratory) for testing support of new and existing projects. Lead the selection of the CLs for analytical method development, validation and testing. Manage the stability programs Reference standard programs and establish shelf-life. Champion, lead and participate in continuous improvement activities for the quality control and analytical development operations Collaborating with cross-functional teams: The Director, CMC-QC Contracts management works with cross-functional teams within Ultragenyx to ensure that contract organizational needs are met. This may involve working with Analytical development, QC, contract organizational teams, and regulatory affairs. Providing strategic input: The Director, CMC-QC Contracts management may be called upon to provide strategic input on QC activities at global contract organizations and serve as QC representation during clinical or commercial campaigns. This involves staying up to date with CMC-QC and CMC sub teams to proactively identify opportunities to solve challenges. Managing contracts and agreements: The Director, CMC-QC Contracts management is responsible for managing contracts and agreements with contract organizations, partners, and stakeholders. This involves negotiating terms and conditions, ensuring compliance with regulatory requirements, and managing any disputes that may arise Manage the qualification/validation of analytical test methods for all Product Quality parameters, specification setting, managing stability programs for clinical and commercial products in accordance with ICH/FDA/EMA/USP/Ph. Eur. Guidelines Author, update, and revise CMC regulatory filing sections to support regulatory filings. Support inspections/audits (regulatory or internal) and author audit observation responses Requirements: Master's degree in Cell Biology, Molecular Biology, Biochemistry or a related life science field; PhD degree is highly desirable Experience with a minimum of 10-12 years in a GMP environment (Biopharmaceutical Industry) with at least 5- 8 years in CMC-QC environment supporting release and stability management of clinical and commercial assets Excellent knowledge in biological molecules methods, including RP-HPLC, IEX, SEC, SDS-PAGE, ELISA and Bioassay, Western blot, 2D western blots, CE and CIEF. Expertise and familiarity with most of the following characterization techniques including LC-MS, MALDI-TOF-MS, CD, FTIR, DSC techniques Excellent oral and written communication skills in English and European languages (preferably German and/or Italian), and proven ability to work autonomously and manage effectively in a matrix environment. Proficiency in MS Office, Word and Excel - Proficiency in statistical analysis (e.g. JMP) software desired Attention to detail, excellent organizational skills and the ability to work on multiple projects with tight deadlines Excellent interpersonal and verbal communications skills and the ability to deal effectively with a variety of personnel both internally and outside the company Travelling to the US head office and other global CMO/CRO sites will be required - 25% #LI-CS1 #LI-Hybrid The typical annual salary range for this full-time position is listed below. This range reflects the characteristics of the job, such as required skills and qualifications and is based on the office location noted in this job posting. The range may also be adjusted based on applicant's geographic location. This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment. Pay Range$197,700-$244,200 USD Full Time employees across the globe enjoy a range of benefits, including, but not limited to: * Generous vacation time and public holidays observed by the company * Volunteer days * Long term incentive and Employee stock purchase plans or equivalent offerings * Employee wellbeing benefits * Fitness reimbursement * Tuition sponsoring * Professional development plans * Benefits vary by region and country Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at XXXX@ultragenyx.com . See our CCPA Employee and Applicant Privacy Notice . See our Privacy Policy . Note to External Recruiters : All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed to : XXXX@ultragenyx.com . PDN-9c0fcd4d-baee-4f91-ba16-f53d4b7507b7
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More About this Listing: Director, CMC-QC Biologics & Oligonucleotides
Director, CMC-QC Biologics & Oligonucleotides is a Executive Director Job at Ultragenyx located in Novato CA. Find other listings like Director, CMC-QC Biologics & Oligonucleotides by searching Oodle for Executive Director Jobs.
Director, CMC-QC Biologics & Oligonucleotides is a Executive Director Job at Ultragenyx located in Novato CA. Find other listings like Director, CMC-QC Biologics & Oligonucleotides by searching Oodle for Executive Director Jobs.